Metyrapone as Additive Treatment in Major Depression
Double-Blind, Placebo Controlled Trial of Metyrapone as Augmenting Agent in the Treatment of Major Depression
1 other identifier
interventional
63
1 country
1
Brief Summary
The purpose of this study is to test whether metyrapone is an effective and safe augmenting agent in the treatment of major depression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 major-depressive-disorder
Started May 1998
Longer than P75 for phase_2 major-depressive-disorder
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 1998
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2001
CompletedFirst Submitted
Initial submission to the registry
July 29, 2005
CompletedFirst Posted
Study publicly available on registry
August 1, 2005
CompletedAugust 12, 2005
July 1, 2005
July 29, 2005
August 11, 2005
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Two psychometric criteria defined by the number of responders and time to onset-of-action. The number of responders was considered twice after 3 and 5 weeks by defining the treatment response as a 30% and 50% reduction
the course of concentrations of ACTH, cortisol, 11-deoxycortisol and DHEA.
Secondary Outcomes (1)
Other psychometric scores, demographic parameters and side effects were considered as secondary variables.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of major depressive disorder; single or recurrent according to DSM-IV criteria (296.2 or 296.3)
- A minimum baseline Hamilton score of 18 points on the Hamilton Rating Scale for Depression (HamD; 21-item version)
- Age from 18 to 75 years
- A drug free period of at least 5 days from antidepressants, antipsychotics, mood stabilizers and all other medications except for mild antihypertensive agents
- A negative urinary drug screening diagnosis
You may not qualify if:
- A current DSM-IV diagnosis for other axis I psychiatric disorders
- Serious medical conditions, especially those associated with adrenal insufficiency
- Pregnancy, nursing or refusal to use a reliable method of birth control in women.
- Participants were randomly assigned to a study group if they met these criteria.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dept. of Psychiatry and Psychotherapy, UKE
Hamburg, Hamburg, 20246, Germany
Related Publications (1)
Jahn H, Schick M, Kiefer F, Kellner M, Yassouridis A, Wiedemann K. Metyrapone as additive treatment in major depression: a double-blind and placebo-controlled trial. Arch Gen Psychiatry. 2004 Dec;61(12):1235-44. doi: 10.1001/archpsyc.61.12.1235.
PMID: 15583115RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Holger Jahn, MD
University Hospital Hamburg-Eppendorf, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 29, 2005
First Posted
August 1, 2005
Study Start
May 1, 1998
Study Completion
July 1, 2001
Last Updated
August 12, 2005
Record last verified: 2005-07